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Completed

NCT Number: NCT06510504

Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1

The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AFFIRM-1 Study Site, Encino, California, United States

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About this study

This is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study medication (225 mg BNC210 or placebo) and approximately 1 hour later participate in a behavioral assessment task. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A current diagnosis of social anxiety disorder as defined in the DSM-5.
  • A Liebowitz Social Anxiety Scale total score of ≥60.
  • Suitable contraception use in line with protocol requirements.
  • Ability to swallow tablets.

Exclusion criteria

  • History of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrum disorder or obsessive-compulsive disorder, or any other Axis I or II disorder which is currently the primary focus of treatment over social anxiety disorder.
  • Hamilton Rating Scale for Depression score of ≥18.
  • Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months.
  • Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening.
  • Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.

Treatment and study plan

225 mg BNC210

Drug

225 mg BNC210

Placebo

Drug

Placebo

Primary outcomes

  1. Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge

    Time frame: Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Performance Phase conducted at 65 to 70 minutes post-dose (following the Anticipation Phase that started at 60 min).

    The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress

Secondary outcomes

  1. Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge

    Time frame: Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Anticipation Phase conducted at 60 to 62 minutes post-dose (the first 2 minutes of the Public Speaking Challenge).

    The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.

  2. Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Clinical Global Impressions-Severity (CGI-S) Score

    Time frame: Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).

    The CGI-S measures overall disease severity of the participant's symptoms as scored by a clinician. Severity is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill of patients) with a higher score indicating a higher level of disease severity.

  3. Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score

    Time frame: Assessed over a single visit: On the treatment day at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).

    The PGI-I is a patient self-reported counterpart of the CGI designed to assess the patient's impression of their perceived change in overall symptoms. Improvement is rated from 1 (very much improved) to 7 (very much worse) with a higher score indicating a higher level of disease severity.

  4. Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score

    Time frame: Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min).

    The State-Trait Anxiety Inventory (State component; STAI-State) is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety.

Sponsors and collaborators

Lead sponsor

Bionomics Limited

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind, 2-arm, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute, As-needed Treatment of Anxiety in Adults With Social Anxiety Disorder

Acronym: AFFIRM-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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